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Sr. Associate, Qa Compliance

3+ years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Sr. Associate, QA Compliance
Location: Ahmedabad, Gujarat, India


Company Overview:

At Baxter, our mission is to save and sustain lives by transforming healthcare with significant medical innovations. For over 85 years, our products and therapies have been crucial in hospitals, clinics, and homes worldwide. Joining Baxter means your work will make a meaningful impact, improving healthcare outcomes for millions of patients. Here, your contributions matter, and you'll experience a sense of purpose in everything you do.


Position Summary:

As a Senior Associate in QA Compliance, you will play a key role in ensuring compliance with regulatory standards and quality guidelines, focusing on external inspections, audits, and maintaining high levels of compliance. This role is essential to ensuring that Baxter's products meet the required safety and quality standards across various stages of production, thereby safeguarding patient safety.


Key Responsibilities:

  • External Inspections:

    • Coordinate and assist in external inspections to ensure compliance with regulatory requirements.

  • Audit Management:

    • Manage and support internal and external audits, ensuring that all regulatory requirements are met.

  • Compliance Oversight:

    • Oversee QA compliance for manufacturing and distribution processes, ensuring all procedures follow established guidelines and regulations.

  • Regulatory Documentation:

    • Ensure timely and accurate documentation for audits, inspections, and quality control activities.

  • Corrective Actions:

    • Address non-conformities identified during audits or inspections, coordinating corrective actions to ensure compliance.

  • Collaboration with Teams:

    • Work cross-functionally with various teams to ensure compliance is maintained across all stages of production.